Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Biomet Sports Medicine, Inc. · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K071816 | HARPOON SUTURE ANCHOR | Biomet Sports Medicine, Inc. | 2007-09-20 | 80 | 0 |
| K071704 | SLEEVE AND BUTTON SOFT TISSUE DEVICES | Biomet Sports Medicine, Inc. | 2007-09-17 | 88 | 0 |
| K070389 | PEEK KNOTLESS ANCHORS | Biomet Sports Medicine, Inc. | 2007-08-09 | 181 | 1 |
| K071498 | SUBTALAR IMPLANT | Biomet Sports Medicine, Inc. | 2007-07-31 | 61 | 7 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda